Breakthrough menopause drug for hot flashes and night sweats gains FDA approval

The federal Food and Drug Administration today approved a new menopause drug that reduces hot flashes and night sweats after the drug was successfully tested at UVA Health and other sites in the United States and around the world.

The drug, elinzanetant, was found to significantly reduce both the frequency and severity of hot flashes while improving women's sleep and quality of life. The nonhormonal drug contains no estrogen and offers an important new option for women who cannot or do not wish to take existing treatment options because of potential side effects, said researcher JoAnn V. Pinkerton, MD, UVA Health's director of midlife health.

"More than a third of women experience disruptive menopausal symptoms that can persist for more than a decade, significantly impacting work, home and quality of life. Many symptomatic menopausal women continue to suffer without treatment and support," said Pinkerton, the U.S. lead for the Oasis II clinical trial that tested the drug. "With the FDA approval of elinzanetant, women will have access to a new, safe and effective therapy for relief of hot flashes and night sweats. Due to its dual receptor antagonism, the studies also showed improvements in sleep and mood." 

Hot flashes and other menopause symptoms

Hot flashes are caused by decreased estrogen levels during menopause and, for some women, years after. Hormone therapy is the most effective treatment for menopause symptoms, but this can come with side effects – usually minor – such as breast tenderness, bloating, headaches or spotting. Less commonly, long-term hormone therapy, particularly oral therapy, can increase the risk of blood clots or strokes or up the risk of certain cancers such as uterine cancer if estrogen is used by itself without a uterine antagonist. There are also contraindications, such as having a prior history of blood clots or estrogen sensitive cancers, that prevent women from being able to take the treatment.

Pinkerton and colleagues across the United States, Europe and Israel tested elinzanetant in the double-blinded Oasis trials to see if it could offer a new alternative. They enrolled postmenopausal women ages 40-65 with moderate to severe hot flashes, randomizing them to receive either 120 mg of elinzanetant daily for 26 weeks or a placebo for 12 weeks followed by 14 weeks of elinzanetant.

Trial results

The women who received elinzanetant reported rapid improvements in their symptoms and quality of life. Both trials revealed statistically significant reductions in hot flash frequency and severity within the first week. At the same time, sleep quality and overall quality of life improved in both trials by week 12.

In addition to evaluating the drug's effect on hot flashes and sleep disruptions, the researchers also looked for potential side effects. Headache and fatigue were the most common, but these were mild. There were no severe side effects, paving the way for FDA approval of the drug.

I am excited that women who can't or choose not to take hormone therapy will have access to elinzanetant, which is an effective and tested, FDA-approved therapy for bothersome symptoms. It's critical that we listen to our patients to understand exactly what they are experiencing and then help them get the support they need, tailored to their individual needs." 

JoAnn V. Pinkerton, MD, UVA Health's director of midlife health